NCT00999817已完成1 期
An Open Label Phase 1, Randomized Cross Over Trial To Estimate The Effect Of PF- 00299804 On The Pharmacokinetics Of Dextromethorphan In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasma AUCinf, AUClast and Cmax of dextromethorphan and dextrorphan when given alone and when given in combination with PF- 00299804.
研究概览
简要总结
A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by CYP2D6 genotyping.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink =5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
- •12 lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of <1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results the study may be permitted on a case by case basis.
- •Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- •History of sensitivity to heparin or heparin induced thrombocytopenia.
- •Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
研究组 & 干预措施
A
Other
Single 30 mg dose of dextromethorphan
干预措施: reference [dextromethorphan] (Drug)
B
Experimental
Single 45 mg dose of PF-00299804 plus a single 30 mg oral dose of dextromethorphan
干预措施: test [PF-00299804 + dextromethorphan] (Drug)
结局指标
主要结局
Plasma AUCinf, AUClast and Cmax of dextromethorphan and dextrorphan when given alone and when given in combination with PF- 00299804.
时间窗: 7 weeks
次要结局
- Plasma Tmax, t1/2, for dextromethorphan and dextrorphan and CL/F, and V/F for dextromethorphan (as data permit).(7 weeks)
- Plasma AUCinf, AUClast, Cmax, Tmax, t1/2, CL/F, and V/F (as data permit) of PF 00299804 when given alone.(7 weeks)
- Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring.(7 weeks)
研究者
研究点 (1)
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